CELGENE-CORPORATION

Celgene International Sàrl, a wholly owned subsidiary of Celgene
Corporation (NASDAQ: CELG), today announced that additional data of
exploratory endpoints from the TOUCHSTONE phase 2 clinical trial of
ozanimod in patients with moderate to severe ulcerative colitis were
presented at the 11th
Congress of the European Crohn’s and
Colitis Organisation (ECCO) in Amsterdam. Ozanimod is an investigational
selective S1P 1 and 5 receptor modulator. These results, included in a
digital oral presentation, showed that ozanimod 1 mg resulted in
improvements in histologic features and remission in patients treated
over 32 weeks.

“It’s exciting to observe histologic improvements in patients with
ulcerative colitis who were treated with ozanimod. Clinical research
suggests that histologic improvements can be linked with improved
clinical outcomes in ulcerative colitis,” said Dr. William Sandborn,
M.D., Professor of Medicine and Chief, Division of Gastroenterology and
Director, University of California San Diego Inflammatory Bowel Disease
Center. “While often more difficult to measure, endpoints such as
histologic improvement or remission are emerging as important treatment
goals for patients and their physicians.”

TOUCHSTONE evaluated the efficacy and safety of 0.5 mg and 1 mg doses of
ozanimod compared with placebo after eight weeks of treatment (induction
phase) in 197 patients with moderate to severe active ulcerative
colitis. Patients who achieved a clinical response at week 8 continued
with their original treatment through week 32 in a maintenance phase.
The primary endpoint was the proportion of patients in remission at week
8. Secondary endpoints were: the proportion of patients achieving a
clinical response, the proportion of patients with mucosal improvement
and the change from baseline in Mayo score. Histologic improvement and
remission with ozanimod at the same time points was assessed as an
exploratory endpoint. Biopsies were scored by a central pathologist
blinded to treatment and sequence. Previously reported results showed
TOUCHSTONE met its primary endpoint and secondary endpoints with
statistical significance for patients on the 1 mg dose of ozanimod
versus placebo.

In the histology results from the TOUCHSTONE study presented at ECCO,
histologic improvement, which was determined by assessing the change
from baseline in Geboes score (12.92 in ozanimod 1 mg, 14.36 in ozanimod
0.5 mg and 13.94 placebo; a decrease in absolute score indicates an
improvement), was significantly greater for the 1 mg dose than for
placebo at both week 8 [Geboes (-4.37 vs. -2.20, p=0.0345)] and week 32
[Geboes (-5.50 vs. -2.24, p=0.0033)]. The 0.5 mg dose resulted in
greater improvement than placebo but the difference did not reach
statistical significance at either time point.

At week 8, although there was an apparent numerical dose response in the
proportion of patients reaching histologic remission, defined as a
Geboes score less than 2, there were no significant differences. However
at week 32, 31 percent (21/67) of patients on ozanimod 1 mg achieved
histologic remission compared with 8 percent (5/65) on placebo
(p=0.0006), and 23 percent (15/65) of patients on ozanimod 0.5 mg
achieved histologic remission (p=0.0164 vs. placebo).

Adverse events (AEs) from the phase 2 study occurred in 26/67 (38.8
percent) patients in the ozanimod 1 mg arm, 26/65 (40.0 percent) in the
ozanimod 0.5 mg arm and 26/65 (40.0 percent) in the placebo arm. The
most common AEs were worsening of ulcerative colitis (3, 2 and 5
patients in the arms outlined above, respectively) and anemia (0, 3 and
4 patients in the arms outlined above, respectively). No AEs of special
interest (cardiac, pulmonary, ophthalmologic, hepatic or serious
infection) were reported during the induction or maintenance phase.

“These data suggest that in addition to benefits we’ve previously seen,
oral ozanimod could also help ulcerative colitis patients achieve the
important treatment goal of histologic remission,” said Scott Smith,
President, Celgene Inflammation & Immunology. “We are committed to
bringing innovative medicines and different treatment options for
patients with inflammatory bowel disease and continue to actively
advance the phase 3 clinical program for ozanimod.”

About the Trial

TOUCHSTONE is a phase 2, randomized, double-blind, placebo-controlled
trial comparing the efficacy and safety of ozanimod (also known as
RPC1063) with placebo in patients with moderate to severe active
ulcerative colitis. A total of 197 patients were randomized and treated
once daily with 1 mg ozanimod (n=67), 0.5 mg ozanimod (n=65) or placebo
(n=65) for 8 weeks (the induction phase). The primary endpoint was the
proportion of patients in remission (Mayo score ≤2, no subscore >1) at
week 8. Secondary endpoints were the proportion of patients achieving
clinical response (reduction in Mayo score of ≥3 and ≥30% with a
decrease in the rectal bleeding score of ≥1 or a rectal bleeding score
≤1), proportion of patients with mucosal improvement (endoscopy score
≤1, and the change in Mayo score. Safety assessments included ECG,
Holter monitoring, pulmonary function testing, optical coherence
tomography and adverse events.

For the maintenance phase, patients who achieved a clinical response at
week 8 continued with their original treatment through week 32.

About Ozanimod

Ozanimod is a small molecule sphingosine 1-phosphate 1 and 5 receptor
modulator in development for immune-inflammatory indications including
relapsing multiple sclerosis and inflammatory bowel disease. Treatment
with S1P receptor modulators is believed to work by interfering with S1P
signaling and blocking the response of lymphocytes (a type of white
blood cell) to exit signals from the lymph nodes, sequestering them
within the nodes. The result is a reduction of circulating lymphocytes
that leads to anti-inflammatory activity by inhibiting migration of
pathologic lymphocytes to sites of inflammation.

Ozanimod is an investigational compound that is not approved for any use
in any country.

About Ulcerative Colitis

Ulcerative colitis is a chronic, relapsing condition triggered by an
abnormal, prolonged immune response that creates long-lasting
inflammation and ulcers (sores) in the mucosa (lining) of the large
intestine (colon). Symptoms usually develop over time, rather than
suddenly. The disease can be debilitating and can sometimes lead to
life-threatening complications. Ulcerative colitis is the most common
form of inflammatory bowel disease worldwide. About one in every 198
people in Europe, and one in every 402 people in North America, have
ulcerative colitis. In 2004, 2.1 million prescriptions were written to
treat ulcerative colitis, and 716,000 ambulatory care visits were
related to the disease. In 2010, there were 107,000 hospitalizations due
to ulcerative colitis.

About Celgene

Celgene International Sàrl, located in Boudry, Switzerland, is a wholly
owned subsidiary and international headquarters of Celgene Corporation.
Celgene Corporation, headquartered in Summit, New Jersey, is an
integrated global pharmaceutical company engaged primarily in the
discovery, development and commercialization of innovative therapies for
the treatment of cancer and inflammatory diseases through gene and
protein regulation. For more information, please visit www.celgene.com
.
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